ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution (NCT01147315) | Clinical Trial Compass
CompletedNot Applicable
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
France13 participantsStarted 2009-11-18
Plain-language summary
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic ORN, radiologically confirmed, for which surgery is indicated
* Presence maximum of 2 outbreaks of ORN
* Oncological remission of the original tumor site for 1 year and for 3 years if the ORN is in the contact or close to the initial tumoral site
* ECOG performance status 0, 1 or 2
* ORN symptomatic accessible to the conservation of at least one cortical mandibular basilar
* Signed informed consent
Exclusion Criteria:
* Oncological treatment
* Haematologic background
* Current bone necrosis consecutive or concurrent to taking bisphosphonates
* Extension of ORN does not allow the retention of a mandibular rod (bicortical form)
* Presence of fracture complicating ORN
* Bisphosphonates during the last year
* Contraindications to the removal of iliac or sternum bone marrow
* Contraindication for general anesthesia